Population Genomic Screening in Primary Care Cooperative Agreement (U01 - Clinical Trial Required)

The National Institutes of Health (NIH), through its National Human Genome Research Institute (NHGRI), has issued a funding opportunity titled "Population Genomic Screening in Primary Care" (Funding Opportunity Number RFA-HG-24-021). This initiative aims to advance research on population-based genomic screening within primary care settings to identify common, actionable genetic conditions. It will fund Clinical Groups (CGs) as part of a pilot program structured as a cooperative agreement, with mandatory clinical trials required. Four to five awards will be granted under this opportunity, offering up to $3.85 million in FY2025 and $4.6 million annually from FY2026 to FY2029. Budgets are limited to $560,000 in the first fiscal year and $680,000 per year in subsequent years, with a maximum project period of five years. This funding is in response to recent recommendations emphasizing the need for genomics-based screening protocols in primary care and addressing critical health disparities. The FOA intends to evaluate the feasibility and impact of genomic screening for approximately 4-7 well-documented genetic conditions. Initial screening will include CDC Tier 1 conditions (hereditary breast and ovarian cancer, Lynch syndrome, and familial hypercholesterolemia), with the potential to add conditions like HFE hemochromatosis and APOL1-associated hypertensive renal disease. Primary care providers (PCPs) in the Clinical Groups will conduct screenings, return results, and follow up on patients found to be at genetic risk. These findings are expected to refine best practices for integrating genomic testing into primary care settings and inform broader population health initiatives. Eligibility is open to higher education institutions, nonprofit organizations, for-profit organizations, and various governmental entities within the U.S. Non-U.S. organizations are not eligible to apply. Applicants are expected to submit via the NIH ASSIST system, Grants.gov Workspace, or an institution’s system-to-system platform. A Letter of Intent is due by November 1, 2024, with the full application due on December 2, 2024. Important dates include scientific merit reviews in March 2025, advisory council reviews in May 2025, and a project start date as early as July 2025. Award recipients will collaborate with a Coordinating Center (CC) and a Sequencing Center (SeqC), each funded under companion FOAs, to ensure data sharing, protocol harmonization, and centralized reporting. CGs selected for funding will be expected to engage diverse community groups and achieve at least 55% enrollment from health disparity populations. Each group will recruit 5,000 patients and focus on effective community engagement, patient follow-up, and integration of screening protocols into electronic health records (EHRs). A Steering Committee, including NIH representatives, will guide protocol development, data analysis, and dissemination of findings. Throughout the program, awardees must contribute to a network-wide protocol that ensures screening and follow-up consistency across all CGs. Applications will be evaluated based on the scientific and technical merits of the proposed project, feasibility, potential impact on primary care settings, and strategies for community engagement and equitable access.